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Dux

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Posted 23 March 2011 - 08:41 AM

Yes.

See clause 7.6.3 of ISO22000.

"Critical limits shall be measureable.
.......'

Critical limits based on subjective data.................."

But I don't know why.

This cause is designed to leave us a chance to misunderstanding OPRP & CCP. right?



GMO

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Posted 23 March 2011 - 08:53 AM

Here is a definition of "subjective":

adj1.belonging to, proceeding from, or relating to the mind of thethinking subject and not the nature of the object beingconsidered2.of, relating to, or emanating from a person's emotions,prejudices, etc: subjective views3.relating to the inherent nature of a person or thing; essential4.existing only as perceived and not as a thing in itself5.med (of a symptom, condition, etc) experienced only by thepatient and incapable of being recognized or studied by anyoneelse6.grammar See also nominative denoting a case of nouns andpronouns, esp in languages having only two cases, thatidentifies the subject of a finite verb and (in formal use inEnglish) is selected for predicate complements, as in It is I

ie it means in itself that the result you get could differ depending on who is observing the result.

It might be easier to think of the opposite, which is "objective". An "Objective" result would be the same, it would be definite whoever did the test.

I'm not an ISO expert but I know BRC asks for clear guidance or examples where critical limits are subjective so this doesn't seem to preclude a subjective critical limit from being a CCP but in practice I would struggle to name one. Perhaps in a catering context, some "thin" foods which need to be cooked (e.g. eggs, bacon) could be defined as cooked by visual means rather than temperature probe.



Modarres

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Posted 23 March 2011 - 12:21 PM

Yes.

See clause 7.6.3 of ISO22000.

"Critical limits shall be measureable.
.......'

Critical limits based on subjective data.................."

But I don't know why.

This cause is designed to leave us a chance to misunderstanding OPRP & CCP. right?


I think the standard required:

If critical limits based on subjective data (such as visual inspection of product, process, handling, etc.) then critical limits shall be supported by instructions or specifications and/or education and training.

Because changing subjective data to measurable critical limits, needs to instructions, specifications or training for enable to measure the critical limits. e.g well-done, ordinary or rare cooking should be defined as 5, 3 or 1 degree of cooking by looking to meat color and tasting and touching (subjective data) and only skilled and trained man could mark the cooking status by number...:bye:

Best Regards,
Modarres

Carlos Leoncini

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Posted 23 March 2011 - 01:22 PM

Yes.

See clause 7.6.3 of ISO22000.

"Critical limits shall be measureable.
.......'

Critical limits based on subjective data.................."

But I don't know why.

This cause is designed to leave us a chance to misunderstanding OPRP & CCP. right?



Carlos Leoncini

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Posted 23 March 2011 - 01:29 PM

Hi. Subjective data can be measured and also can be analyzed and monitored through statistics. This particular application is called control charts for attributes. For example: p charts (fraction defective), np charts (number of defectives), c charts (number of defects), u charts (number of defects per unit). Using this concept, you can also meet ISO 22000-4.2.1/5.1/5.2 by determining and documenting, measurable objectives for your food safety system.

I hope this helps.



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Charles.C

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Posted 24 March 2011 - 12:10 PM

Dear Dux,

If you look through the background of the development of ISO 22000, the aspect of Control Measures which had no easily defined quantitative limits but could be considered "critical" was one of the core reasons for the introduction of OPRP.
(I guess I'm validating the last line of yr post :smile: )


Rgds / Charles.C


Kind Regards,

 

Charles.C


SriramB

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Posted 02 April 2011 - 10:26 AM

Yes.

See clause 7.6.3 of ISO22000.

"Critical limits shall be measureable.
.......'

Critical limits based on subjective data.................."

But I don't know why.

This cause is designed to leave us a chance to misunderstanding OPRP & CCP. right?



Hi Dux,

Clause 7.6.3 is simply addressing 'Critical limits" for Critical Control Points.
As the next line in IS22K elaborates, it is just the limits to watch out for, for whatever 'Monitoring' we do at that CCP.

Now, if the monitoring was of a 'variable' such as temperature, pressure etc, then we insure the accuracy of the monitoring by stuff like "Calibration of the equipment etc..." This would be the 'objective measurements.

But, if the monitoring was of an "attribute" such as " rinser water hitting base of bottle (to clean) " , then we would insure the "adequacy' of this attribute by training, the operator, providing visual comparison aids etc.

( Here I would like to acknowledge "Carlos Leoncini" for actually detailing the statistical tools that help us to deal with attributes in a scientific and logical manner.)

In short, the CCP monitoring has to be able, to be compared to logically derived "upper and / or lower limits" which ensure the CCP is in control. There is no restriction on whether the parameter being monitored has to be an "numerical variable" or " subjective attribute".

Within this clause, the OPRPs are not referred/relevant.

------------------

With OPRP, as with other PRP they are a "Pre requisite" and hence our HACCP is built on the premise that these are in place and implemented to a level where their effectiveness is adequate to control the hazards they address.

As with other PRP they would have their own 'monitoring' to ensure this. --- 7.5.C (in IS22K)

---------------------
Many thanks for raising such an interesting topic..:smile:

Cheers,

Sriram


Charles.C

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Posted 02 April 2011 - 02:59 PM

Dear SriramB,

With OPRP, as with other PRP they are a "Pre requisite"


To my understanding OPRP are a consequence of the hazard analysis.?? Perhaps we have a different interpretation of "Prerequisite". :smile:

Rgds / Charles.C

Kind Regards,

 

Charles.C


GMO

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Posted 02 April 2011 - 07:10 PM

Hmm, this is an off topic but interesting point. Prerequisite implies it is applied first and in general IMO that's right for PRPs, it is your basis for HACCP but oPRPs can't really be identified until the hazard analysis has started. I think that's one of the bad things about oPRPs because as I said, in general PRPs are applied first before your hazard analysis and reviewed alongside the hazard analysis to check they're sufficient.

Personally I think the oPRP concept introduces a grey area which is bad for HACCP (in general, for people who live and breathe HACCP, I don't think it's a problem but for people that don't it's an 'easy' answer to those difficult questions when they have ambiguity about whether it's a CCP or not. Personally I'd rather a decision is made. It's like when you give people 3 answers, yes, no, maybe; everyone picks 'maybe'.)



SriramB

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Posted 02 April 2011 - 08:06 PM

Dear SriramB,



To my understanding OPRP are a consequence of the hazard analysis.?? Perhaps we have a different interpretation of "Prerequisite". :smile:

Rgds / Charles.C



HI Charles,

You are right, I should have clarified...

The OPRP is the outcome of the HA rather than a Prerequiste suggested by common sense, legal, regulatory or specs such as PAS, GMP etc.

In reply to DUX's issue, what I was trying to say was that once an OPRP has been identified (by HA), then its treatment is similar to PRP, in the sense, that implementation of the said OPRP needs to be aasured and taken 'for granted' , for the HA to be valid to that process. ( so OPRP is a prerequiste for the food safety insurance by HACCP to be effective , similar to normal PRP being prerequisite to providing a ideal,hygienic, safe platform for the operation to work)

I also like 'GMO' s explanation that PRPs are 'basis' for HACCP, and it does take some juggling inside ones mind, to identifiy an OPRP during the HA and then declaring it as a required 'basis' for HA for that particular operation.

In a very simplistic manner you could say that you are acknowledging the importance of that particular program, albeit not part of the production process, as being super critical to the control of a food safety hazard, directly, in that operation.

p.s. IME OPRPs become a very clear concept after a couple of whisky's :smile:

Cheers,

SriramB


Charles.C

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Posted 02 April 2011 - 10:41 PM

Dear SriramB / GMO,

Slightly :off_topic:

I agree with a lot of the points in previous posts.(particularly GMO's opinion on the practical implementation of "day-to-day HACCP"). As per usual i disagree with some also. I don't think it can be true that OPRPs are intended to not be included as reflecting part of the production process. Or maybe I misunderstood that bit in the last post.?(then again, i haven't had any whisky yet today) :smile: Purely as a suggestion, maybe it can be said that the selection of OPRPs overlaps the "conventional" PRPs and the (general) manufacturing process?

I think ISO really struggled with the OPRP concept. They had decided that it was conceptually crucial to extend the traditional HACCP philosophy regarding control measures and initially presented this particularly via linkages to the prerequisite aspect (which goes right back to early HACCP of course). Unfortunately, I think, problems appeared in how to make their ideas practical for application at the "ground" level. The drafts/ discussions prior and almost up to to 2005 contain a variety of manouevrings of emphasis involving the "prerequisite" terminologies which are somewhat mindboggling at times, ie almost incomprehensible to me :smile: . The final internal/external compromises on the PRP/OPRP/CCP aspect as presented in the 2005 standard are IMO the cause of the, again IMO, logical difficulties in the implementation of the standard for that topic. The rapidly issued 22004 sort of attempts to smooth out some of the illogicalities with varying degrees of success (IMO).
It seems to me the choice of the name "operational prerequisite" is ultimately and practically, very unfortunate but it's too late to change it now :smile: .

I attach a chunk which illustrates the flavour of the OPRP/CCP idea around 2005. Thanks to the (intended?) expansion of HACCP subjectivity as a result of the standard, I wouldn't claim that all of the content necessarily applies today (or even then for some experts! [particularly the last 2 paragraphs ;) ].)

Question
I saw in a booklet published by my Federation a diagram (and a decision tree) which shows that all the PRPs must be considered again at the time of the categorization of control measures to an oPRP or to a CCP. I do not understand this: I thought that categorization related only to measures associated with specific hazards.
Requirements of the standard (extract)
7.4.4 Selection and assessment of control measures
Based on the hazard assessment of 7.4.3, an appropriate combination of control measures shall be selected which is capable of preventing, eliminating or reducing these food safety hazards to defined acceptable levels.

Answer
The aim of PRPs, by definition (see § 3.8 of the standard) is to create " basic conditions and activities that are necessary to maintain a hygienic environment suitable for the production ". They are thus not addressing specific hazards.
Concerning specific hazards, identified as needing to be controlled, ISO 22000 requires the selection of (combinations of) control measures – which will then be categorized to either an oPRP, or the HACCP plan (or to CCPs).

These control measures will be selected either among or outside the implemented PRPs .
Thus, according to the hazards and, in particular, on the degree of industrialization, these measures will be often selected outside of the basic PRP of the branch. Examples:
• pasteurization of drinking milk: the pasteurizer will be actually selected among the basic PRPs of the branch; on the other hand, one may add a laminar flow at the filling, which is not part of the basic PRP;
• slicing and packaging of cooked ham: the basic PRPs will include obligatorily rules such as personal hygiene and the climate in the slicing room, measures which will probably belong to the combination selected; in addition, the passage into clean room and the control of the passage time of the ham which could be added to the combination selected and not to the basic PRP of the branch.

In addition, selected control measures can as well come from other levels in the food chain. Examples:
• assembly of salad & chicken sandwiches: the PRPs of the branch are limited to the level of processing, with primarily rules of personal hygiene and temperatures; control of hazards such as nitrate residues and pesticides in salad (in fact bought precut from a wholesaler) will require to rest on measures which belong to the PRPs of primary production, such as EurepGAP certification, producers under contract, etc;
• in the same sandwich, the control of hormone residue hazards in the chicken meat will be resolved by the decision to take meat only from a country prohibiting the use of hormones in breeding, control measures which do not form part of the basic PRP of the branch.

08. How do you distinquish between an oPRP & the HACCP plan?
Question
I would like to know more about oPRPs. Is the difference with the HACCP plans the fact that the significant hazard does not have a CCP? Can you give me a clear example of an application?

Answer
The standard should be read attentively (see § 7.4.4). All items must be understood and established by respecting the following logical sequence:
• identification of hazards which require to be put under control (or "significant" hazards according to your terminology) – see § 7.4.3 ISO 22000
• selection of one (combination of) control measure associated with this hazard
• validation of the (combination of ) control measure
• categorization of this (combination of) control measure to an oPRP or HACCP plan.

One can see that the question is badly formulated: a hazard cannot "have or include a CCP", but it will suppose control measures which will then be categorized as belonging to an oPRP or in the HACCP plan.

In this issue, the essence lies in the selection of control measures which must be effective and validated. The storm generated by the question of knowing whether a control measure belongs to a CCP or an oPRP is without doubt a residue of the application of Codex and its tree… where, if there was no CCP, there was nothing!

With ISO 22000, it is necessary to move the priority on the selection of control measures, by ensuring that they address all the real hazards to control. Once one has the control measures and they are credible (effective and validated), in the final analysis it does not matter if one allots them to a CCP or to an oPRP: indeed, in both cases it will be necessary to build a monitoring system to prove the effectiveness of it.

For the method of categorization to a CCP or an oPRP, the ProCert ISO 22000 tree may be helpful to carry out this categorization, based on two key criteria (mentioned in ISO 22000) which characterize a CCP:
• « controlling » : aptitude of the (combination of) control measure to eliminate the hazard (examples: pasteurization of milk for a salmonella hazard; filtration for a foreign body hazard
• « monitoring »: the possibility of having an on-line follow-up of the control measure.

If the two conditions are met, it is a CCP (pasteurization in our example). If on-line monitoring is not ensured, it is an oPRP (filtration in our example).

Rgds / Charles.C

Kind Regards,

 

Charles.C


SriramB

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Posted 02 April 2011 - 10:59 PM

Hi Charles,

Funny seeing the comments from 2005! Thanks for sharing.

You have started me thinking if the 'language' is contributing more to the confusion than the actual concept, so, st the risk of going off topic completely,, I wonder if ISO is translated into other languages and if things are clearer in those.

Just a thought :smile:



Charles Chew

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Posted 04 April 2011 - 05:14 AM

There is absolutely no problem with the technical terms used under the ISO 22000 scheme whether you are referring to OPRPs or PRPs. With the acceptance of FSSC 22000 by GFSI as one of the several recognized schemes, this confirms that the use of such terms have its applications and are not ambiguous as sometimes claimed.

Nevertheless, I like to stress that PRPs and OPRPs are used concurrently to support each other where implementation data for verification activities are measured for the purposes they are intended. Therefore, the composition of FSSC22000 being an integration of ISO 22000 + PAS 220 together with GFSI approved scheme status should remove any doubts on any terminologies published under the ISO 22000 standard. By the way, in any hazard analysis, PRPs are also established to support the HACCP plan as well. So indeed, PRPs are independent and as such, is one of the core control measure combinations. ISO 22000 is a powerful standard and is even better with PAS 220 in the picture.


Cheers,
Charles Chew
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SriramB

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Posted 04 April 2011 - 11:17 AM

There is absolutely no problem with the technical terms used under the ISO 22000 scheme whether you are referring to OPRPs or PRPs. With the acceptance of FSSC 22000 by GFSI as one of the several recognized schemes, this confirms that the use of such terms have its applications and are not ambiguous as sometimes claimed.

Nevertheless, I like to stress that PRPs and OPRPs are used concurrently to support each other where implementation data for verification activities are measured for the purposes they are intended. Therefore, the composition of FSSC22000 being an integration of ISO 22000 + PAS 220 together with GFSI approved scheme status should remove any doubts on any terminologies published under the ISO 22000 standard. By the way, in any hazard analysis, PRPs are also established to support the HACCP plan as well. So indeed, PRPs are independent and as such, is one of the core control measure combinations. ISO 22000 is a powerful standard and is even better with PAS 220 in the picture.


Dear Charles Chew,

Congratulations on such a confident assertion. ( Hope this draws some interesting rebuttals :lol: )

I have highlighted your comments which I feel are very relevant and I guess, I have been trying to articulate same in my previous posts, without much success :smile:

Looking forward to reading more comments from the team..


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Posted 04 April 2011 - 06:51 PM

Dear Charles Chew,

I would replace the word "sometimes' with "invariably". :biggrin:

Would hv liked to see the validation aspect equally nailed as well. :thumbup:

Guess there was really no need to issue ISO 22004 after all.

Now can we all also agree that HACCP is absolutely, in no way, subjective (sorry, i meant ambiguous) ? :smile:

Rgds / Charles.C


Kind Regards,

 

Charles.C


APPAJI

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Posted 15 June 2011 - 10:29 AM

Dear All,
Since I am from India and with lot of traditional food preparations and no modern tools are used but people are well experience in cooking.
I take an example that If there is deep frying and it will be CCP then the Critical limit is the Temp. of the oil when frying is done. Now at traditional preparation unit they do not have thermometer to measure at each frying. This is visually checked for correct temp. by putting small portion of item to be fried in oil and if the portion rises to surface then it is considered frying temperature is attained. This is subjective activity depending on Visual inspection.
I Consider the rising of food item in oil as critical limit for correct frying. This need to be validated and shown.
Simillarly there are many such operations where practically monitoring with instruments are not possible that does not meen there are no Critical limits. We have to identify the practical most trusted action for such work.Otherwise small operators who are not in position of buying modern sophisticated equipment's can never have HACCP in place.

Hope this is a help.
Regards
Appaji



GMO

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Posted 15 June 2011 - 11:15 AM

Dear All,
Since I am from India and with lot of traditional food preparations and no modern tools are used but people are well experience in cooking.
I take an example that If there is deep frying and it will be CCP then the Critical limit is the Temp. of the oil when frying is done. Now at traditional preparation unit they do not have thermometer to measure at each frying. This is visually checked for correct temp. by putting small portion of item to be fried in oil and if the portion rises to surface then it is considered frying temperature is attained. This is subjective activity depending on Visual inspection.
I Consider the rising of food item in oil as critical limit for correct frying. This need to be validated and shown.
Simillarly there are many such operations where practically monitoring with instruments are not possible that does not meen there are no Critical limits. We have to identify the practical most trusted action for such work.Otherwise small operators who are not in position of buying modern sophisticated equipment's can never have HACCP in place.

Hope this is a help.
Regards
Appaji



That's an interesting example. I would counter challenge though that for the product they're making, you may find that the core temperature required to achieve a good quality product exceeds the temperature required to make a safe product which would suggest it would be an oPRP not a CCP... Posted Image



mind over matter

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Posted 15 June 2011 - 02:46 PM

Customer satisfaction is subjective but you can measure it e.g. surveys, personal visits, etc





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